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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Intersept Tubing Packs

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 Class 2 Device Recall Medtronic Intersept Tubing Packs see related information
Date Posted December 28, 2012
Recall Status1 Terminated on April 04, 2013
Recall Number Z-0618-2013
Recall Event ID 63769
510(K)Number K800178  K891687  K012538  K113845 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:

0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1.

Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432

Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.

Code Information Pack Model Pack Lot
0E27R16- 11239917
11252800
11264666;
1A30R6- 12132577
12219267;
2493R24- 11187015
11199707
11224309
11227205
11556735;
2493R25- 11646941
11713200
11745242
11813334
11852673
11886412
11990393
12033630
12114699
12178107
12191642
12450856;
5D56R5- 11298229
11357085
11465358
11541270
11601193
11654853
11702415
11745232
11766305
11822320
11838721
11852677
11930380
12024708
12166379
12292156;
5Z93R4- 11713132
11736880
11749958
11766283
11808651
11860604
11878689
11911068
11948473
5Z93R5- 12236493;
12411746
7E64R2- 11933798;
7J53R2- 12172725;
7M13R1- 12168157;
7M14R1- 12349772;
7N16R- 12349786;
7P25R1- 12327801
12449801
12457250;
7P93R1- 12349795
12374420;
7Q11R1- 12344028
12456303;
BB7L63R2- 12408737;
BB7N26R- 12312571;
CB5174R11- 11293051
11315344
11334856
11489271
11745162
11886341
11977682
12019852
12062713
12098852
12139621
12146752
12258941
12277502
12326468
12421465
206110946;
CB5175R13- 11292866
11334859
11432873
11442937
12182778
12411655;
CB5Q03R6- 11713162
11766245
11787583
11923139
11934952;
CB5Q03R7- 12114626;
CB6C53R6- 12423767;
CB7C15R2- 12411647;
CB7C59R2- 11731501;
11813316
11838743
11869767
11908794
11982413
12019907
12146796
12151706
12201727
12292133
12423702;
CB7C60R2- 11687047
11724030
11843434
11878672;
CB7C74R2- 11895167;
CB7D91R5- 11961280
12130493
12146882
12191604
12277455
12411687
12423760;
CB7E35R2- 11839101;
CB7E38R1- 11843886
11885844
11990360
12105025
12133083
12159400;
CB7G21R4- 12032413
12033728
12040524
12083359
12360622;
CB7L48R1- 12301694;
CB7L72R1- 12155258;
CB7P82R1- 12440601;
HY6U96R2- 206133995;
HY6Y52R2- 11826276;
HY7E87R1- 11830948
11898103
11923498
12323794
12435409;
SS7J91R3- 12175428;
SSCB7L48R- 12120109;
SSTL7G78R1 -11986264;
TL5S33R7- 12093478;
12139612
12172589
12315375;
TL6V77R1- 11217931
11260111;
TL7B51R1- 11559097
11622968
11664762
11687063
11712834;
TL7G20R3- 12258680
12271138
12360554
TL7G78R3- 12067309;
TL7R87R1- 206114578
206145379
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
763-526-6000
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall
Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
FDA Determined
Cause 2
Package design/selection
Action Medtronic sent a "Urgent Medical Device Customer Notification" letter dated November 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected product and to return affected product, but if they have concerns about replacement than they recommend to inspect and return any damaged product.. For further questions please contact your local Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. Outside the US, please call 1+763-526-7890. We apologize for any inconveniences this issue may have caused you or your institution.
Quantity in Commerce 1552
Distribution Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC VASCULAR
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